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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00118716 |
During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. All study related medications and medical examinations are provided at no cost. All study drugs are currently available by prescription to patients 4 years and older.
Condition | Intervention | Phase |
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Activity/Exercise Induced Bronchospasm |
Drug: Fluticasone propionate/salmeterol |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and Adolescent Subjects With Activity-Induced Bronchospasm |
Estimated Enrollment: | 230 |
Study Start Date: | December 2003 |
Ages Eligible for Study: | 4 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | SFA100314 |
Study First Received: | July 1, 2005 |
Last Updated: | October 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00118716 History of Changes |
Health Authority: | United States: Food and Drug Administration |
asthma bronchospasm |
Anti-Inflammatory Agents Spasm Neurotransmitter Agents Bronchial Spasm Salmeterol Bronchial Diseases Adrenergic Agents Adrenergic beta-Agonists Anti-Asthmatic Agents Asthma |
Anti-Allergic Agents Adrenergic Agonists Asthma, Exercise-Induced Hypersensitivity Respiratory Tract Diseases Hypersensitivity, Immediate Fluticasone Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |
Anti-Inflammatory Agents Respiratory System Agents Neurotransmitter Agents Bronchial Spasm Bronchial Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic Agonists Hypersensitivity Respiratory Tract Diseases Therapeutic Uses Fluticasone Dermatologic Agents |
Salmeterol Adrenergic beta-Agonists Immune System Diseases Asthma Anti-Asthmatic Agents Anti-Allergic Agents Pharmacologic Actions Asthma, Exercise-Induced Autonomic Agents Hypersensitivity, Immediate Peripheral Nervous System Agents Bronchodilator Agents Respiratory Hypersensitivity |